Pectasides Dimitrios, Pectasides Eirini, Papaxoinis George, Koumarianou Anna, Psyrri Amanda, Xiros Nikolaos, Tountas Nikolaos, Kamposioras Konstantinos, Papatsibas George, Floros Theofanis, Gouveris Panagiotis, Karageorgopoulou Sofia, Economopoulos Theofanis
Second Department of Internal Medicine, Propaedeutic, Oncology Section, University of Athens, Attikon University Hospital, Haidari, Athens, Greece.
Anticancer Res. 2009 Feb;29(2):769-75.
The aim of this study was to evaluate the activity and toxicity of docetaxel, vinorelbine and oral estramustine in androgen-resistant prostate cancer (ARPC).
Fifty-two eligible patients were treated with docetaxel at 30 mg/m2 (day 1 and 8), vinorelbine at 20 mg/m2 (day 1 and 8), and oral estramustine of 280 mg p.o. (daily on days 1 to 7) every 3 weeks for 12 cycles. Patients with osseous metastases received zoledronic acid of 4 mg every 3 weeks. Low molecular weight heparin was administered on a prophylaxis basis to all patients.
A prostate-specific antigen (PSA) response > or = 50% from baseline was obtained in 29 (56%; 95% confidence interval [CI], 42-70%) patients. Objective responses among the 25 patients with measurable disease were observed in 48% (95% CI, 27-69%), including 1 patient with complete response (CR) and 11 patients with partial response (PR). Patients with extraosseous only, skeletal only, and extraosseous and skeletal metastases showed different PSA responses (87% vs. 44% vs. 59%, respectively, p = 0.094). Furthermore, patients with soft tissue disease only showed insignificantly better PSA response than those with skeletal metastases (response rate: 87% vs. 50%, p = 0.064). The median progression-free survival was 7.6 months (95% CI, 6.7-8.4 months) and the median overall survival was 18.2 months (95% CI, 15.5-20.8 months). The only parameters which were found to have an impact on survival were the extent of disease and the baseline levels of PSA. Toxicity was generally mild except for myelotoxicity. Neutropenia grade 3/4 was recorded in 33% of patients and 6% experienced febrile neutropenia. Anemia and thrombocytopenia grade 3 or 4 were not a problem. Three patients (6%) developed grade 3 sensory neuropathy and 2 patients (4%) developed grade 3 fatigue. Edema grade 3 occurred in 1 (2%) patient and thromboembolism grade 3 occurred in 2 (4%) patients.
The combination of docetaxel, vinorelbine and oral estramustine is a well-tolerated regimen with high biochemical and objective response rates in patients with ARPC.
本研究旨在评估多西他赛、长春瑞滨和口服雌莫司汀在雄激素抵抗性前列腺癌（ARPC）中的活性和毒性。
52例符合条件的患者接受多西他赛30mg/m²（第1天和第8天）、长春瑞滨20mg/m²（第1天和第8天）以及口服雌莫司汀280mg口服（第1至7天每日服用），每3周进行12个周期的治疗。有骨转移的患者每3周接受4mg唑来膦酸治疗。所有患者均预防性使用低分子量肝素。
29例（56%；95%置信区间[CI]，42 - 70%）患者的前列腺特异性抗原（PSA）从基线水平下降≥50%。在25例可测量疾病的患者中，观察到客观缓解率为48%（95%CI，27 - 69%），包括1例完全缓解（CR）患者和11例部分缓解（PR）患者。仅存在骨外转移、仅存在骨转移以及同时存在骨外和骨转移的患者PSA反应不同（分别为87%对44%对59%，p = 0.094）。此外，仅患有软组织疾病的患者PSA反应略优于患有骨转移的患者（缓解率：87%对50%，p = 0.064）。无进展生存期的中位数为7.6个月（95%CI，6.7 - 8.4个月），总生存期的中位数为18.2个月（95%CI，15.5 - 20.8个月）。发现对生存有影响的唯一参数是疾病范围和PSA的基线水平。除骨髓毒性外，毒性一般较轻。33%的患者记录到3/4级中性粒细胞减少，6%的患者发生发热性中性粒细胞减少。3或4级贫血和血小板减少不是问题。3例（6%）患者出现3级感觉神经病变，2例（4%）患者出现3级疲劳。1例（2%）患者出现3级水肿，2例（4%）患者出现3级血栓栓塞。
多西他赛、长春瑞滨和口服雌莫司汀联合方案耐受性良好，在ARPC患者中具有较高的生化缓解率和客观缓解率。
